Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition

Not Applicable

• Conditions: Narcolepsy

• Registration Number: NCT00484757
• Lead Sponsor: Zentrum für Integrative Psychiatrie

Brief Summary

15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-08
• Study First Submitted QC: 2007-06-08
• Study First Posted: 2007-06-11
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-02
• Last Update Posted: 2009-04-03
• Primary Completion: 2009-08
• Study Completion: 2009-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Narcolepsy
• Age >18
• Informed consent
• GERMAN fluently spoken

Exclusion Criteria

• Additional severe psychiatric or somatic disorders
• Pregnancy or nursing
• Anemia (Hb<10g/dl)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Effect of orexine A on sleep, neurocognition and immune-system

Trial Locations

Locations (1)

Zentrum für Integrative Psychiatrie; 🇩🇪 Kiel, Germany